PainNCT06012747
Pain After Cesarean Section - A Danish Multicenter Cohort Study.
An observational study of Pain and Cesarean Section, run by Nordsjaellands Hospital at 19 sites in Denmark.
Trial summary
Pain after a cesarean section is of moderate to severe intensity. A Danish multicenter study from 2021 used an obstetric Quality of Recovery score 24 hours after the cesarean section and found that 45% of 861 patients had experienced very severe pain during recovery. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pain, Cesarean Section, Recovery
- What is being tested?
- Questionnaire
- How many people
- 752 participants
- Where
- 19 sitesDenmark
- Study dates
- 1 Sep 2023to 31 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Adult
Study population: Danish patients > 18 years old who undergo planned cesarean section under spinal anesthesia
Who may be able to join
None listed.
Who cannot join
- Age < 18 years
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Denmark19 sites
Department of Anesthesia, Åbenrå Hospital
Aabenraa
Department of Anesthesia, Aalborg University Hospital
Aalborg
Department of Anesthesia, Århus University Hospital
Aarhus
Department of Anesthesia, Copenhagen University Hospital, Rigshospitalet
Copenhagen
Department of Anesthesia, Esbjerg Hospital
Esbjerg
Department of Anesthesia, Gødstrup Hospital
Gødstrup
Department of Anesthesiology, Copenhagen University Hospital, Herlev
Herlev
Department of Anesthesiology, Copenhagen University Hospital, North Zealand Hillerød
Hillerød, 3400
Department of Anesthesia, Hjørring Sygehus
Hjørring
Department of Anesthesia, Holbæk Hospital
Holbæk
Department of Anesthesia, Horsens Hospital
Horsens
Department of Anesthesiology, Copenhagen university Hospital, Hvidovre
Hvidovre
Department of Anesthesia and Intensive care, University Hospital of Southern Denmark, Kolding
Kolding
Department of Anesthesia, Nykøbing Falster Hospital
Nykøbing Falster
Department of Anesthesia, Odense University Hospital
Odense
Department of anesthesia, Randers Sygehus
Randers
Department of Anesthesia, Zealand University Hospital, Roskilde
Roskilde
Department of Anesthesia, Slagelse Hospital
Slagelse
Department of Anesthesia,Viborg, Regional Hospital
Viborg
About this study
Pain after a cesarean section is of moderate to severe intensity. A Danish multicenter study from 2021 used an obstetric Quality of Recovery score 24 hours after the cesarean section and found that 45% of 861 patients had experienced very severe pain during recovery.
This result was surprisingly high but also unspecific. Therefore, the investigators aim to investigate the intensity of pain experienced by patients at specific time intervals after the cesarean section e.g., every 6th hour. Additionally, the investigators will examine whether the pain has an impact on important functions for both the patients and the newborns, as well as assess the overall morphine consumption.
Read more
All Danish regions have approved the REDCap database as a secure way to collect and store data. REDCap can also send encrypted links that can be converted into SMS messages sent to the participants' mobile phones at fixed intervals, allowing participants to enter data directly into the secure system. The investigators also aim to feasibility test the system.
When a child is delivered by cesarean section, it is an expectation that the mother can take care of herself and the baby a few hours after the surgery. However, severe pain can hinder this. Therefore, it is important to investigate whether pain relief for our patients is sufficient.
Based on response rates and the frequency of outcomes, data from this observational study can support the design of a future national multicenter randomized controlled trial (RCT) with a focus on postoperative pain intervention. The incidences of binary outcome measures and standard deviations of continuous outcome measures will support the sample size calculations for our RCT.
- Conditions
- Pain, Cesarean Section, Recovery
- Being tested
- Questionnaire
- Keywords
- Pain, Cesarean Section, Recovery, REDCap
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
The patients receive a questionnaire every 6 hours during the first 24 hours after their cesarean section, and again after 2, 7, and 30 days.
What is being measured
The primary outcome is the main question the study is designed to answer.
Self reported pain on movement from supine position to sitting position after 24 hours, NRS 0-10
Patient reported
Measured: 24 hours after cesarean section
Composite outcome of self reported morphine side effects occurring within 24 hours For vomiting and urinary retention, this is recorded as yes/no, where yes is considered a side effect.
consisting of either nausea, dizziness, itching, vomiting, or urinary retention.
Nausea, itching, and dizziness are recorded on a 4-point scale: None, mild, moderate, severe. Where moderate and severe are considered side effects.
For vomiting and urinary retention, this is recorded as yes/no, where yes is considered a side effect.
Measured: 24 hours after cesarean section
Neonatal admission ,
yes/no
Measured: within 24 hours
Secondary outcomes (1)
See protokol for the multible secondary and exploratory outcomes
See protokol for the multible secondary and exploratory outcomes
Measured: 0-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start1 Sep 2023
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 752 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Duch, Nordsjaellands Hospital
- Investigators
- Patricia Duch, MD, Principal investigator, Hillerod Hospital, DenmarkHelene Nedergaard, MD, Ph.D, Study chair, Kolding Sygehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012747
- Sponsor's protocol ID
- 100
- Status last verified
- Jun 2024
- First submitted
- 10 May 2023
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Each participating site has access to the data, which can be viewed by the project managers. Once all the data is collected, it will be anonymized and used for calculations. After the data is published, each participating site can have control over its own data but can only publish it with the permission of the project managers.
Publications
Duch P, Nedergaard HK, Jorgensen CC. Mobilisation, breastfeeding, and quality of recovery after caesarean delivery: a nationwide prospective cohort study in Denmark with secondary analysis on the association with severe pain. Int J Obstet Anesth. 2026 May;66:104863. doi: 10.1016/j.ijoa.2026.104863. Epub 2026 Jan 21.
PubMed 41619519Duch P, Wikkelso A, Jorgensen CC, Jakobsen JC, Mathiesen O, Norskov AK, Nedergaard H; on the behalf of the National Pain after Cesarean Section (PACS) Working Group . And in collaboration with CEPRA a consortium initiative for peri-operative research (www.cepra.nu). Pain and adverse effects after caesarean delivery: A nationwide prospective cohort study. Eur J Anaesthesiol. 2026 Jan 1;43(1):34-44. doi: 10.1097/EJA.0000000000002277. Epub 2025 Sep 22.
PubMed 40956058
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain After Cesarean Section - A Danish Multicenter Cohort Study.
- ClinicalTrials.gov ID
- NCT06012747
- Acronym / sponsor ID
- 100
- Conditions
- Pain, Cesarean Section, Recovery
- Keywords
- Pain, Cesarean Section, Recovery, REDCap
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 752 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pain after a cesarean section is of moderate to severe intensity. A Danish multicenter study from 2021 used an obstetric Quality of Recovery score 24 hours after the cesarean section and found that 45% of 861 patients had experienced very severe pain during recovery.
This result was surprisingly high but also unspecific. Therefore, the investigators aim to investigate the intensity of pain experienced by patients at specific time intervals after the cesarean section e.g., every 6th hour. Additionally, the investigators will examine whether the pain has an impact on important functions for both the patients and the newborns, as well as assess the overall morphine consumption.
All Danish regions have approved the REDCap database as a secure way to collect and store data. REDCap can also send encrypted links that can be converted into SMS messages sent to the participants' mobile phones at fixed intervals, allowing participants to enter data directly into the secure system. The investigators also aim to feasibility test the system.
When a child is delivered by cesarean section, it is an expectation that the mother can take care of herself and the baby a few hours after the surgery. However, severe pain can hinder this. Therefore, it is important to investigate whether pain relief for our patients is sufficient.
Based on response rates and the frequency of outcomes, data from this observational study can support the design of a future national multicenter randomized controlled trial (RCT) with a focus on postoperative pain intervention. The incidences of binary outcome measures and standard deviations of continuous outcome measures will support the sample size calculations for our RCT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Danish patients > 18 years old who undergo planned cesarean section under spinal anesthesia
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireThe patients receive a questionnaire every 6 hours during the first 24 hours after their cesarean section, and again after 2, 7, and 30 days. | Other | – |
Primary outcome
Self reported pain on movement from supine position to sitting position after 24 hours, NRS 0-10
Time frame: 24 hours after cesarean section
Patient reported
Composite outcome of self reported morphine side effects occurring within 24 hours For vomiting and urinary retention, this is recorded as yes/no, where yes is considered a side effect.
Time frame: 24 hours after cesarean section
consisting of either nausea, dizziness, itching, vomiting, or urinary retention. Nausea, itching, and dizziness are recorded on a 4-point scale: None, mild, moderate, severe. Where moderate and severe are considered side effects. For vomiting and urinary retention, this is recorded as yes/no, where yes is considered a side effect.
Neonatal admission ,
Time frame: within 24 hours
yes/no
1 secondary outcome
See protokol for the multible secondary and exploratory outcomes
Time frame: 0-30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Derived from this study: PubMed 41619519Duch P, Nedergaard HK, Jorgensen CC. Mobilisation, breastfeeding, and quality of recovery after caesarean delivery: a nationwide prospective cohort study in Denmark with secondary analysis on the association with severe pain. Int J Obstet Anesth. 2026 May;66:104863. doi: 10.1016/j.ijoa.2026.104863. Epub 2026 Jan 21.
- Derived from this study: PubMed 40956058Duch P, Wikkelso A, Jorgensen CC, Jakobsen JC, Mathiesen O, Norskov AK, Nedergaard H; on the behalf of the National Pain after Cesarean Section (PACS) Working Group . And in collaboration with CEPRA a consortium initiative for peri-operative research (www.cepra.nu). Pain and adverse effects after caesarean delivery: A nationwide prospective cohort study. Eur J Anaesthesiol. 2026 Jan 1;43(1):34-44. doi: 10.1097/EJA.0000000000002277. Epub 2025 Sep 22.
- Individual participant dataSharing planned: Undecided. Each participating site has access to the data, which can be viewed by the project managers. Once all the data is collected, it will be anonymized and used for calculations. After the data is published, each participating site can have control over its own data but can only publish it with the permission of the project managers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Duch, MD principal investigator
Hillerod Hospital, Denmark
Helene Nedergaard, MD, Ph.D study chair
Kolding Sygehus
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Cesarean Section, run by Nordsjaellands Hospital at 19 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self reported pain on movement from supine position to sitting position after 24 hours, NRS 0-10 (time frame: 24 hours after cesarean section). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06012747, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024; AzTrials last refreshed its copy on 29 Oct 2026.